PillCam SB Gets Expanded Indication in US

Given Imaging out of Yoqneam, Israel has received FDA clearance to market the firm’s PillCam SB video capsules and the accompanying Agile pills for children two years of age and older. The PillCam SB is a swallowable video device meant for imaging of the small intestine onto an embedded memory chip and Agile is a supporting product for testing the gastrointestinal tract for clear passage of the PillCam.

— PillCam SB is used by physicians to evaluate patients and detect small bowel abnormalities, such as obscure GI bleeding, iron deficiency anemia, suspected Crohn’s disease, suspected small intestinal tumors, polyposis syndromes, as well as in suspected or refractory malabsorptive syndromes, such as celiac disease.— The Agile Patency System is an accessory to the PillCam video capsule intended to verify adequate patency of the gastrointestinal tract in patients with known or suspected strictures prior to administration of the PillCam video capsule. Clinical situations in which physicians may wish to confirm patency include suspicion of strictures due to Crohn’s disease, chronic NSAID use, tumors and radiation enteritis.
PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Patient friendly in nature, PillCam endoscopy typically is used on an outpatient basis and has been clinically validated, as evidenced by more than 1,000 peer-reviewed publications. To date, more than 1,000,000 patients worldwide have benefited from Given Imaging’s PillCam capsule endoscopy.
Previously PillCam SB and Agile were indicated for children 10 years and older. PillCam SB is cleared for the visualization of the small bowel mucosa and may be used as a tool for the detection of abnormalities of the small bowel.